Table 3 Progression criteria rules

If one or more of the criteria^a meet the ‘stop’ thresholds, then the study should not progress towards a definitive cRCT, unless there are clear ‘modifiable’ contextual or design issues (i.e. related to the intervention or study procedures) which have been identified

If one or more of the criteria^a meet the ‘amend’ thresholds, then these will be discussed with the TSC to ascertain whether there is enough evidence that sufficient improvements can be made to proceed to a definitive cRCT

If all the criteria^a meet the ‘go’ thresholds, then with the appropriate amendments (if needed), the study should proceed towards a definitive cRCT